Prescribing Information

Megestrol acetate oral suspension contains a form of the hormone progesterone and is used to treat anorexia, wasting (cachexia), or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). This medication is available in generic form. Common side effects include diarrhea, weight gain, nausea, rash, impotence, insomnia, mood swings, sweating, breakthrough menstrual bleeding, high blood pressure, and flatulence.

The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/day). Megestrol acetate oral suspension may interact with other drugs. Tell your doctor all medications and supplements you use. Megestrol acetate should not be used during pregnancy. It may cause fetal harm. Because of the potential for adverse effects on a nursing baby, breastfeeding should be discontinued if megestrol acetate oral suspension is required.

Our megestrol acetate oral suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

SIDE EFFECTS

Clinical Adverse Events: Adverse events which occurred in at least 5%
of patients in any arm of the two clinical efficacy trials and the open trial
are listed below by treatment group. All patients listed had at least one post
baseline visit during the 12 study weeks. These adverse events should be considered
by the physician when prescribing megestrol acetate oral suspension.

ADVERSE EVENTS
% of Patients Reporting

Trial 1
(N=236)

Trial 2
(N=87)

Megestrol Acetate
mg/day
No.of Patients

Placebo
0
N=34

100
N=68

400
N=69

800
N=65

Placebo
0
N=38

800
N=49

Open Label Trial
1200
N=176

Diarrhea

15

13

8

15

8

16

10

Impotence

13

14

6

14

0

14

17

Rash

19

19

4

12

3

12

16

Flatulence

19

10

1

19

3

10

16

Hypertension

10

10

0

18

0

10

14

Asthenia

13

12

3

16

8

14

15

Insomnia

10

13

4

16

0

10

11

Nausea

19

14

0

15

3

14

15

Anemia

16

13

3

15

0

10

10

Fever

13

16

4

15

3

12

11

Libido Decreased

13

14

0

15

0

12

11

Dyspepsia

10

10

3

13

5

14

12

Hyperglycemia

13

10

6

13

0

10

13

Headache

16

10

1

13

3

10

13

Pain

16

10

0

12

5

16

14

Vomiting

19

13

0

12

3

16

14

Pneumonia

16

12

0

12

3

10

11

Urinary Frequency

10

10

1

12

5

12

11

Adverse events which occurred in 1 to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo.